Text Size

Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00359177
First received: July 28, 2006
Last updated: May 31, 2012
Last verified: February 2011
History of Changes
  Purpose

The purpose of the study is to evaluate how subjects with mild or moderate liver problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.


Condition Intervention Phase
Vomiting
Renal Impairment
 Drug: GW679769
 Phase 1

Study Type: Interventional
Official Title: An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Hepatic Impairment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 24
Study Start Date: December 2005
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy or have mild or moderate hepatic impairment
  • Females: Non-childbearing (hysterectomy, bilateral oophorectomy, post-menopausal), childbearing (negative pregnancy test, abstinence, double-barrier contraception, vasectomized partner)
  • Negative for Hepatitis B and C(healthy subjects)
  • Negative drug, alcohol and HIV tests

Exclusion criteria:

  • Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function
  • Encephalopathy
  • Active peptic ulcer disease
  • Drug or alcohol abuse
  • Pregnant or lactating
  • Esophageal bleeding
  • Heart failure
  • Infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359177

Locations
United States, Florida
GSK Investigational Site
Gainesville, Florida, United States, 32608
GSK Investigational Site
Orlando, Florida, United States, 32809
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00359177     History of Changes
Other Study ID Numbers: NKT102785
Study First Received: July 28, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
emesis liver problems hepatic impairment GW679769

Additional relevant MeSH terms:
Vomiting
Renal Insufficiency
Liver Diseases
Signs and Symptoms, Digestive
 Signs and Symptoms
Kidney Diseases
Urologic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013